Author Archives: Joana Carvalho

Weill Neurohub Unites 3 Academic Centers with DOE Scientists to Advance Tools, Treatments for MS and Other Ills

Three academic research institutions launched the Weill Neurohub initiative, an effort to speed the discovery and development of therapies for neurological diseases that include multiple sclerosis (MS), Parkinson’s and Alzheimer’s disease, and for psychiatric disorders like anxiety, depression, and schizophrenia. The initiative unites three West Coast…

7T MRI Reveals New Insights into Some RRMS Features

With the help of 7 Tesla magnetic resonance imaging (MRI), investigators discovered that leptomeningeal enhancement — a radiographic finding indicative of brain inflammation — is more common than previously thought in people with relapsing-remitting multiple sclerosis (RRMS), and is tied to lesions in specific regions of the brain.

Medical Marijuana Now Available to MS and Other Patients in Louisiana

Medical cannabis products, jointly developed by GB Sciences Louisiana (GBSL) and the Louisiana State University Agricultural Center's (LSU AgCenter) Therapeutic Cannabis Program, are now available for purchase by qualified patients with illnesses that include multiple sclerosis (MS) at nine state-licensed pharmacies. The decision, announced by the Louisiana Department of Agriculture & Forestry, marks the first time that cannabis-based products are available to patients in that state with qualifying medical conditions. Louisiana joins more than 30 U.S. states in allowing medical use of marijuana in some form. In addition to MS, conditions for which medical cannabis will be available as treatment in Louisiana include: Different types of cancer Positive status for human immunodeficiency virus (HIV) Acquired immune deficiency syndrome (AIDS) Cachexia (wasting syndrome) Seizure disorders Epilepsy Spasticity (muscle tightness) Crohn's disease Muscular dystrophy Glaucoma Parkinson's disease Severe muscle spasms Intractable pain Post-traumatic stress disorder (PTSD) Autism spectrum disorder (ASD) People diagnosed with any of these disorders who wish to have access to medical cannabis need a "recommendation form" issued by a certified healthcare professional. That recommendation of therapeutic benefit, rather than a prescription, needs to be taken to any of the nine licensed pharmacies to obtain the products. "This is a watershed moment for our company and the State of Louisiana, reflecting many years of research and development by GB Sciences into the cannabis plant's biopharmaceutical applications," John Davis, president of GB Sciences Louisiana, said in a press release. "For the first time, medical cannabis patients in Louisiana have access to safe, tested products with formulations designed to improve their health and wellbeing," Davis added. The first GBSL products available for sale include three different formulations of sublingual tinctures sold in 30 ml bottles: a tetrahydrocannabinol (THC)-rich compound (300 mg/ml), a cannabidiol (CBD)-rich compound (40 mg/ml of CBD, and 2 mg/ml of THC), and a balanced compound (5 mg/ml of THC, and 5 mg/ml of CBD). CBD and THC are the two most abundant cannabinoids found in cannabis, the plant genus that includes both hemp and marijuana. "The LSU AgCenter is excited about the opportunity therapeutic cannabis will provide patients in Louisiana, and we are looking forward to research initiatives that will help us to understand the full potential of this medicinal plant," said Bill Richardson, LSU vice president for agriculture. The Louisiana Legislature passed the Alison Neustrom Act in 2015, setting the foundation for the production and use of cannabis-based products for medical purposes. The LSU AgCenter, in collaboration with GBSL, is one of the two institutions given an official license to cultivate cannabis under this act. The other is Southern University.

Under-the-skin CBD Infusion With Valeritas’ h-Patch Device Prolongs Therapy Effects, Study Finds

Valeritas Holdings' proprietary h-Patch device can be used to administer cannabidiol by an under-the-skin (subcutaneous) infusion, prolonging the time the medication remains in circulation in the body and maximizing its therapeutic effects, a preclinical study has found. Cannabidiol (CBD) is a cannabis-derived, purified liquid formulation that has strong anti-seizure, and anxiolytic, or anxiety-reducing properties. Based on findings from multiple clinical trials, the U.S. Food and Drug Administration (FDA) approved CBD — sold under the brand name Epidiolex, by GW Pharmaceuticals — in June 2018 for the treatment of children with Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy that fail to respond to treatment with conventional anti-epileptic medicines. Meanwhile, other studies have suggested that CBD also may help reduce pain, muscle tightness (spasticity), and inflammation in people with multiple sclerosis (MS). For that reason, cannabidiol should be included in current standard-of-care therapies for these patients, the researchers say. "CBD has tremendous pharmaceutical potential. However, the poor bio-availability and other issues that result from oral dosing are major shortcomings that increase the cost and variability of treatment," Ilo E. Leppik, MD, the former president of the American Epilepsy Society, and current professor of neurology and pharmacy at the University of Minnesota, said in a press release. Bio-availability refers to the extent and rate at which a medication is absorbed by the body's circulatory system after being administered. Researchers note that CBD's bio-availability, when administered orally, is estimated to range between 6 and 10%. "We have found that a fatty meal can increase the amount of CBD absorbed by five times, compared to that taken on an empty stomach, so there is a dire need for an improvement in the consistency of dosing. Subcutaneous [under-the-skin] administration would have two advantages: it would greatly increase the bio-availability thus reducing the amount needed, and it would eliminate the variability of diet on CBD uptake," Leppik said. Now, the medical technology company Valeritas has announced that its proprietary h-Patch device can be used to administer CBD by an under-the-skin infusion. According to findings from a pilot preclinical study, this method can effectively overcome the issues found in oral administration. In the study, CBD was delivered over a single 24-hour period using the h-Patch. Two CBD dosage regimens were tested: 40 mg/24h,  and 76 mg/24h. Key findings from the study showed that CBD was rapidly absorbed and distributed in the body when administered through an under-the-skin infusion over a period of 24 hours using the h-Patch device. Moreover, CBD levels in the bloodstream rose quickly within an hour after the start of the infusion, and were still detectable 24 hours after the end of the infusion. The effects were similar with the two CBD dose regimens tested. "This study highlights Valeritas’ partnering opportunities to leverage the h-Patch technology beyond insulin delivery," said John Timberlake, president and CEO of Valeritas. "Subcutaneous infusion is a powerful delivery method for a variety of drugs with solubility, permeability, and first-pass metabolism challenges, and the h-Patch may offer a cost-effective alternative means of reliable and patient-friendly drug dosing." The company's V-Go insulin delivery device is the first product based on the h-Patch technology that has been approved by the FDA. Valeritas is now planning to present the detailed findings from the preclinical study with CBD at an upcoming medical conference later this year. “In the United States alone, approximately 160 clinical trials with CBD are currently enrolling patients or preparing to do so. Disease targets include epilepsy, PTSD, pain, cardiovascular disease, gastrointestinal disorders, multiple sclerosis, eye conditions, spinal cord injuries, addiction, and cancer,” Leppik concluded.

Rutgers Health Leading Program to Support MS Children

Rutgers Health is leading the Pediatric Multiple Sclerosis and Demyelinating Diseases Program, the only program in the state of New Jersey designed specifically to support children with multiple sclerosis (MS). The support program seeks to promote children’s access to cutting-edge therapies and clinical trials, and to educate…

3-D Brain Models of PPMS and Parkinson’s Off to Space Station for Research in Microgravity

The National Stem Cell Foundation announced the start of a pioneering project to investigate the impact of microgravity on the neurodegeneration associated with primary progressive multiple sclerosis and Parkinson's disease. The project, a collaboration between the New York Stem Cell Foundation Research Institute, the Summit for Stem Cell, and investigators with Aspen Neuroscience, will send 3-D brain organoids derived from patients with these disorders, for a first time, to the International Space Station on SpaceX CRS-18. This flight, set to launch on July 21 from the Kennedy Space Center in Cape Canaveral, Florida, is a test run for a 30-day study of neurodegeneration in microgravity set to take place on the space station this fall. "The National Stem Cell Foundation is delighted to be funding innovative science at the frontier of new drug and cell therapy discovery. The leading-edge research findings that have developed through this collaboration between important research groups may fundamentally alter our understanding of how and why neurodegeneration occurs," Paula Grisanti, chief executive officer of the NSCF, said in a press release. These organoids, or 3-D cellular brain models, contain microglia — cells that normally support and protect neurons. Microglia are implicated in the brain inflammation and disease progression seen in people with Parkinson's, PPMS, and other neurodegenerative disorders. The project will allow scientists in the near absence of gravity to study how these cells interact with each other, migrate, send and receive chemical signals, change their genetic signature, and promote brain inflammation. As such, investigators may get a glimpse of all the biological mechanisms involved in PPMS and Parkinson's in ways not feasible on Earth. This work might lead to understandings and advancements with a direct impact on the development of medicines and cell therapies for neurodegenerative diseases. Space Tango is leading the transport and maintenance logistics, to ensure the cells arrive at the ISS in the best possible condition and remain viable during the 30 days they will remain in orbit. To that end, the company has developed a series of automated systems intended to surpass conventional lab techniques, and allow space station researchers to work with a higher number of samples than typical, and use high-throughput techniques to easily analyze them. According to the company, these automated systems are not intended exclusively for research on the ISS, but may also be used by research facilities worldwide to support and accelerate scientific innovation. "The vision the National Stem Cell Foundation brings to using new approaches to science and creating collaborations between leading experts in Parkinson’s disease and multiple sclerosis from across the country is truly unique," said Jana Stoudemire, commercial innovation officer at Space Tango. "In addition to supporting the development of tissue chip platforms for microgravity, Space Tango is excited to expand capabilities for human 3-D brain organoid models that will assist in studying some of the most challenging diseases we have yet to truly understand," Stoudemire added. "We are very pleased to support this important research on the ISS."

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